FDA Orders Review of Heart Devices

The U.S. Food and Drug Administration ordered
St. Jude Medical Inc.
to launch new studies gauging the scope of heart-device failures that have plagued the company for months.

The agency said Thursday the studies should focus on its Riata defibrillator leads that were recalled in December. But, FDA officials have also asked St. Jude to beef up continuing studies of the company's newer Durata-series leads. The potentially life-threatening failures that led to the Riata recall haven't yet been linked to Durata, but the FDA warned the devices are similar.

Leads connect the heart to defibrillators, implantable devices that zap irregular heart rhythms back to normal. Wires inside Riata leads break through their insulation with unusual frequency. A recent study conducted by St. Jude found the problems occurred in about 19% of more than 700 patients with Riata leads. St. Jude stopped selling Riata leads in late 2010.

In addition to the Riata study, St. Jude is collecting data about Durata performance in three patient registries,
Amy Jo Meyer,
a St. Jude spokeswoman said. The company has highlighted differences between Riata and Durata, including design changes and a new coating meant to improve the integrity of its insulation.

The company said in a statement that it supports post-market surveillance, and would work with the FDA "to understand the ongoing performance of our leads and the initiation of any additional studies."

The FDA said it is aware of St. Jude's existing studies but regulators want even more detail. "The FDA is looking for a very thorough investigation of this problem," said
Bran Zuckerman,
chief of cardiovascular devices at the FDA. The agency "wanted to make sure this is done at the present time," he said.

The FDA's decision to require St. Jude to more closely monitor the so-far-unscathed Durata leads could pique concerns that Riata's problems will bleed into the slate of heart-rhythm products St. Jude still sells. The FDA is asking, for instance, that St. Jude routinely X-ray patients enrolled in post-market Durata studies to detect any potential insulation problems, an agency official said. St. Jude announced in May that it would X-ray Durata patients when doctors replace defibrillator batteries in one such study. The company's heart rhythm division accounts for more than 50% of its revenue.

In the wake of the FDA's move, St. Jude's stock was down nearly 4% in midafternoon trading.

The Durata lead "is sufficiently similar" to the recalled Riata product to merit closer examination, said
Mitchell Shein,
the FDA's branch chief for pacing and defibrillation devices. "We don't have enough long-term performance data to be sure it won't have this problem," he said.

When a report surfaced in June that a Florida doctor had identified a single broken Durata lead, the company's stock fell 6% by that day's close. St. Jude later confirmed that the failure didn't reflect the insulation problems faced by Riata, but the episode revealed investors' wariness of any hint of Durata flaws.

The decision to request further studies and data was based on a review of "an amalgamation of scientific data" that became available over the last year detailing Riata's problems, said the FDA's Dr. Zuckerman.

The FDA is seeking new details about the number of Riata patients with insulation failures, links between insulation problems and electrical problems that can cause the devices to malfunction, and adverse events caused by lead problems, such as complications from surgeries to remove the leads.

"Increased surveillance of these leads is appropriate and in the best interest of patients," said
Robert Hauser,
a cardiologist at the Minneapolis Heart Institute. Dr. Hauser is expected to publish a study soon analyzing reports of Durata failures gathered in an FDA database.

St. Jude's stock is down more than 15% since March, when Dr. Hauser published a study linking 20 deaths to Riata failures, sparking a fresh wave of scrutiny.

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